GORE EXCLUDER AAA Endoprosthesis PXT311415Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132610341), received between Jan 15, 2019 and Apr 30, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (P020004); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2009, THE PATIENT PRESENTED WITH AN AORTIC ANEURYSM WHICH WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS USING PXT311415 (TRUNK AND IPSILATERAL LEG), PXL161007 (ILIAC EXTENDER) AND PXC121000 (CONTRALATERAL LEG). ON (B)(6) 2021, THE PATIENT PRESENTED AT THE HOSPITAL WITH GROWTH OF THE ANEURYSMAL SAC. IT REMAINS UNCLEAR WHAT CAUSED THE GROWTH. REPORTEDLY, COMPUTED TOMOGRAPHY ANGIOGRAPHY IMAGING DEMONSTRATES A SMALL CLOUD OF CONTRAST JUST BELOW THE INFRARENAL NECK. ON (B)(6) 2021, A REINTERVENTION WAS PERFORMED TO TREAT THE SAC GROWTH. THE PHYSICIANS PERFORMED MULTIPLE ANGIOGRAPHY IMAGING TO FIGURE OUT WHERE THE ENDOLEAK CAME FROM, BUT IT WAS NOT VISIBLE. REPORTEDLY, THERE WAS 4 MM SEAL TO GAIN IN THE PROXIMAL NECK, SO AN GORE® EXCLUDER® AAA ENDOPROSTHESIS PLA360400 WAS PLACED BELOW THE RENAL ARTERIES. IN THE LEFT AND RIGHT COMMON ILIAC ARTERY WAS SEAL TO GAIN AS WELL, SO ON THE RIGHT SIDE A GORE® EXCLUDER® AAA ENDOPROSTHESIS PLC141000 WAS IMPLANTED AND ON THE LEFT SIDE A PLC161200 WAS IMPLANTED. THEY STATED, THAT FINAL ANGIOGRAPHY IMAGING SHOWED A GOOD RESULT. REPORTEDLY, THE PHYSICIANS FINALLY SUSPECTED A PATIENT POSITION ENHANCED ENDOLEAK, BECAUSE THE CONTRALATERAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757356 ↗
• InjuryDec 8, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2012 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE A PROXIMAL TYPE I ENDOLEAK WAS REPORTED. ON (B)(6) 2020 REINTERVENTION WAS PERFORMED TO TREAT THE PROXIMAL TYPE I ENDOLEAK. IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED A 4-VESSEL BRANCHED FENESTRATED DEVICE, EFFECTIVELY SEALING ABOVE THE PATIENT'S VISCERAL ARTERIES. REPORTEDLY THE PHYSICIAN DID NOT REVIEW THE ORIGINAL CT FILMS SO WAS UNABLE TO DESCRIBE A CAUSE OF THE PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN DID NOTE THAT THE PATIENT'S AORTIC NECK WAS DISEASED WITH NO AVAILABLE INFRARENAL SEAL ZONE. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE INTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 10970182 ↗
• InjuryJul 8, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2019, COMPUTED TOMOGRAPHY REVEALED AN ENDOLEAK OF INDETERMINATE ORIGIN. IMAGES WERE EVALUATED ON JUNE 12, 2019, THAT REVEALED ANEURYSM ENLARGEMENT AND A PATENT INFERIOR MESENTERIC ARTERY.

  Patient problems: Aneurysm

  MAUDE report 8769608 ↗
• InjuryJan 15, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON AN UNKNOWN DATE IN 2010, THE PATIENT PRESENTED WITH AN UNCOMPLICATED ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS STATED THAT THE PATIENT HAD A TREATED HYPERTENSION AS A CARDIOVASCULAR RISK FACTOR. ON (B)(6) 2018, THE ENDOGRAFT WAS EXPLANTED BECAUSE OF THE ENLARGEMENT OF THE ANEURYSM SACK DUE TO A TYPE I ENDOLEAK.

  Patient problems: No Code Available

  MAUDE report 8247282 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020004. One submission often covers many models, so check the product and lot details in each record.

• Z-0996-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)
• Z-0995-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER AAA Endoprosthesis